DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to investigate and confirmed the failure was in the unit's history log, but was unable to duplicate reported failure.Performed full functional check and safety test.Ran unit in clinical mode for three consecutive days without any errors or issue.The iabp was returned to the customer for clinical service.
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Event Description
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It was reported that when powered on, the cardiosave intra-aortic balloon pump (iabp) had a vacuum failure and autofill failure.It was further reported that it is a reoccurred issue.Since the patient was not connected to the unit, there was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, h2, h6 (type of investigation), h10.
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Event Description
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It was reported that when powered on, the cardiosave intra-aortic balloon pump (iabp) had a vacuum failure and autofill failure.It was further reported that it is a reoccurred issue.Since the patient was not connected to the unit, there was no patient involvement, and no adverse event reported.
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